INTRODUCTION
IncobotulinumtoxinA (INCO; Xeomin®, Bocouture®; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) is the only commercially available botulinum toxin A (BoNT/A) preparation free from complexing proteins.1 INCO is currently approved in worldwide markets and in the United States to treat glabellar frown lines (GFL) at a dose of 20 Units (U) and in the European Union at a dose of 20–30U.
The duration of effect for glabellar lines is approximately 3–4 months in Phase 3 studies investigating the FDA-labeled dose of 20U for INCO, OnabotulinumtoxinA (ONA; Botox®/Vistabel®, Allergan Inc.) and PrabotulinumtoxinA (PRA; Nabota®, Daewong Therapeutics, Korea/ Jeuveau®, Evolus Inc., USA/Nuceiva®, Evolus Inc., Canada, Europe), as well as the FDA-labeled dose of 50U for AbobotulinumtoxinA (ABO; Dysport®/Azzalure®, Ipsen Pharma, Wrexham, UK).2-4 In the first large, randomized, multicenter, double-blind study to investigate FDA-labeled doses, equivalence between INCO and ONA in the treatment of GFL at the 20U dose in 250 subjects was demonstrated using an investigator-assessed responder rate (≥1-point improvement from baseline on the Facial Wrinkle Scale [FWS] at maximum frown). Similar efficacy profiles were demonstrated at all timepoints (1, 2, 3, and 4 months). Additionally, patient satisfaction was high (>90%) for both treatment groups. In both studies, INCO and ONA were found to be well tolerated.5 This study supported an earlier head-to-head study demonstrating non-inferiority to ONA in 381 subjects.6
The duration of effect for glabellar lines is approximately 3–4 months in Phase 3 studies investigating the FDA-labeled dose of 20U for INCO, OnabotulinumtoxinA (ONA; Botox®/Vistabel®, Allergan Inc.) and PrabotulinumtoxinA (PRA; Nabota®, Daewong Therapeutics, Korea/ Jeuveau®, Evolus Inc., USA/Nuceiva®, Evolus Inc., Canada, Europe), as well as the FDA-labeled dose of 50U for AbobotulinumtoxinA (ABO; Dysport®/Azzalure®, Ipsen Pharma, Wrexham, UK).2-4 In the first large, randomized, multicenter, double-blind study to investigate FDA-labeled doses, equivalence between INCO and ONA in the treatment of GFL at the 20U dose in 250 subjects was demonstrated using an investigator-assessed responder rate (≥1-point improvement from baseline on the Facial Wrinkle Scale [FWS] at maximum frown). Similar efficacy profiles were demonstrated at all timepoints (1, 2, 3, and 4 months). Additionally, patient satisfaction was high (>90%) for both treatment groups. In both studies, INCO and ONA were found to be well tolerated.5 This study supported an earlier head-to-head study demonstrating non-inferiority to ONA in 381 subjects.6